Senior System Engineer - Product Safety & Risk Management

Senior System Engineer - Product Safety & Risk Management

As a Senior Systems Engineer you will contribute to the creation and maintenance of high-quality products, meeting user, business and regulatory requirements. You will manage complexity and show technical leadership and effective stakeholder management.

Your role:

• You will be an expert leading our teams in the domain of product safety risk management
• You are part of the Systems Engineering group in MR R&D
• You will oversee the engineering team's execution to ensure designs meet criteria for quality, safety and reliability, while maintaining comprehensive risk management related documentation and advancing system engineering practices
• You will conduct risk assessments, implement control measures, and support regulatory submissions to align with medical standards and ensure product safety throughout the life cycle, including support of complaint investigations and post-market surveillance
• You are aware of ISO 14971 and its implications for medical device development and are comfortable communicating and implementing the standard in your work context.
• You are able to work with industry standard document management systems.
• You are comfortable using office tooling to create and maintain documentation.

You're the right fit if:

• You hold a Bachelor’s degree in a relevant field* and have a minimum of 7 years of relevant work experience OR a Master’s degree in a relevant field* and a minimum of 5 years of relevant experience. A PhD degree in a relevant field* would be a plus. *relevant fields: safety engineering, mechanical engineering, electrical engineering, physics
• You hold 5+ years of Quality/Risk Management experience and have experience creating risk management deliverables in a highly regulated industry (preference will be given to the medical device/healthcare industry)
• Extensive experience in product development and preferrably post-market surveillance in a highly regulated industry (preference will be given to the medical device/healthcare industry)
• You have a strong drive to maintain state of the art risk management files
• Experience with audits would be considered a plus
• You can work independently but also as part of a team
• You can influence the thinking of, and gain acceptance from, others including stakeholders and take responsibility for timely decisions.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This role is an office role.

*This role is not open to relocation.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did.

Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team.

We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while transforming themselves personally and professionally.

Working at Philips is more than a job. It's an experience filled with unexpected moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.